EPIDEMIOLOGICAL AND BEHAVIORAL RESEARCH IN ORAL HEALTH
RELEASE DATE: November 14, 2003
PA NUMBER: PA-04-022
The R01 portion of this funding opportunity has been replaced by PA-07-169,
which now uses the electronic SF424 (R&R) application for February 5, 2007
submission dates and beyond.
EXPIRATION DATE: November 1, 2006, unless reissued.
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov/)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Dental and Craniofacial Research (NIDCR)
(http://www.nidcr.nih.gov/)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.121 (Oral Diseases and
Disorders)
THIS PA CONTAINS THE FOLLOWING INFORMATION
o Purpose of the PA
o Research Objectives
o Mechanism(s) of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS PA
This PA seeks to stimulate epidemiological and behavioral research to improve
oral health or increase the understanding of the determinants of oral health.
This initiative addresses specific research opportunities identified in the
NIDCR Strategic Plan (http://www.nidcr.nih.gov/about/strat-plan/) issued in
2003 and in NIDCR’s Plan to Eliminate Oral Health Disparities
(http://www.nidcr.nih.gov/research/healthdisp/hdplan.pdf. Such research
projects will contribute to the Institute’s clinical research programs by
providing a clearer understanding of behavioral and environmental factors
influencing oral health, oral health care, and the prevention, diagnosis, and
treatment of specific oral diseases/conditions.
RESEARCH OBJECTIVES
Background:
Oral, dental, and craniofacial diseases are among the most common health
problems affecting individuals in the US (Oral Health in American: A Report
of the Surgeon General, 2001). The prevalence of most oral diseases is
influenced by biological, behavioral, and environmental factors. Such
factors include, for example, diet, personal self care behavior, tobacco and
alcohol use, environmental influences such as the availability of fluoridated
community water, access and motivation to seek preventive and therapeutic
professional oral health care, health care providers’ decisions and practice
behaviors, genetic influences, bacterial exposures, and immunological status.
A better understanding of risk factors for oral diseases, and of the
behavioral and environmental influences on oral health and dental treatment
outcomes is needed.
Over the past three decades, oral health in the US overall has improved.
Among most age groups, the average number of teeth per person affected by
dental caries has decreased and more US adults are keeping their natural
teeth. Nevertheless, as noted in Oral Health In America: A Report of the
Surgeon General and in the recent NIDCR Strategic Plan, profound differences
in the prevalence of oral diseases persist.
Dental caries and the periodontal diseases are very prevalent in the US. Both
are caused by bacteria in dental plaque (biofilm) and are influenced by
environmental, genetic and behavioral factors. While the prevalence of dental
caries has declined in the past three decades, it remains the most common
chronic childhood disease in the U.S. By age 17, more than 80 percent of U.S.
adolescents are affected by this disease. The poor and uninsured, the very
young and the elderly, and those with compromising medical conditions or
disabilities are at increased risk for dental caries. The periodontal
diseases range from mild forms of gingivitis to severe forms of periodontitis
that results in tooth loss. Almost half of US adults age 35 to 44 have
gingivitis, a reversible inflammation of the gingiva. Approximately one-
fourth has periodontitis with clinical attachment loss of at least 4
millimeters. Severe periodontal disease (6 millimeters or more of clinical
attachment loss) affects 14 percent of adults ages 45 to 54, and 23 percent
of 65- to 74-years old. Tobacco use is a major risk factor for the
development and progression of periodontal diseases. Diabetes, particularly
if poorly controlled, increases the risk for periodontal disease.
Sjögren’s syndrome is an autoimmune condition involving the salivary glands.
It affects between 1 and 4 million Americans, mostly middle age women.
Individuals with cystic fibrosis are also at high risk for salivary gland
dysfunction, as are the estimated 40,000 people per year who lose salivary
gland function as a result of radiation treatment for head and neck cancer.
Individuals lacking adequate saliva commonly experience rampant tooth decay,
mucosal infections such as candidiasis, loss of taste, and oral discomfort.
Acute or chronic dental or craniofacial pain afflicts approximately ten per
cent of the adult population. Sources of orofacial pain include caries,
periodontal diseases, and neuropathic and musculoskeletal conditions.
Orofacial pain is a major symptom of temporomandibular muscle and joint
disorders (TMJD), currently estimated to affect at least ten million people
in the United States.
Craniofacial anomalies are among the most common of all birth defects. Cleft
lip and cleft palate occur in about 1 to 2 out of 1,000 births in the United
States. Many other rarer disorders, such as the ectodermal dysplasias,
Treacher Collins syndrome, Apert’s syndrome, and Waardenburg syndrome include
oral and craniofacial manifestations and share with cleft lip/palate the
potential for producing significant functional, esthetic and social
consequences across the entire life span. In addition, oral facial injuries
can lead to serious disfigurement or problems with speech or chewing. Oral
and craniofacial injuries occur throughout life and can result from a variety
of causes such as athletic activities, failure to use appropriate protective
equipment, interpersonal violence, falls, and vehicular accidents. To date,
only limited research has addressed the epidemiology, prevention, and
behavioral concomitants of craniofacial injuries.
Numerous studies indicate that poorer individuals in the US are significantly
more likely to have fewer diagnostic and preventive dental visits compared
with persons with more economic resources. Minorities, the elderly, and
children on Medicaid and other low-income children have fewer preventive
dental visits. A lack of preventive care is correlated with poorer oral
health. For example, more than a third (36.8 percent) of poor children aged 2
to 10 were found to have untreated decayed teeth compared to 17.3 per cent of
nonpoor US children. Rural residents are less likely to receive preventive
dental care than their urban counterparts. Predisposing and enabling factors
(e.g., attitudes, health literacy, access to insurance) are strongly
predictive of use of dental services. For many medical conditions,
individuals who are sick are more likely to seek and receive medical care
than are those who are healthy. In contrast, people who have the most dental
needs often are the same people who seek or receive the least dental care.
Studies are needed to identify determinants of seeking dental care and
elucidate processes through which appropriate preventive oral health care can
be encouraged among all people.
NIDCR’s Strategic Plan
The NIDCR’s Strategic Plan supports studies that expand and enhance the
integration of population-based, genetic, social, and behavioral research.
Specific research activities highlighted in the Strategic Plan and relevant
to this PA include but are not limited to:
o Further the understanding of how genetic, behavioral and environmental
factors interact to contribute to disease susceptibility or resistance;
o Assess and bridge gaps in the knowledge, opinions, and practices of the
public, educators, and health care professionals about oral diseases and
their prevention;
o Identify risk factors and markers for the progression of disease to oral,
dental and craniofacial diseases and disorders;
o Improve oral health literacy;
o Develop more effective strategies to encourage the appropriate and timely
adoption of research findings into clinical practice.
Examples of studies that may be responsive to this program announcement are
given below. The list is only for illustrative purposes and is not
exhaustive. Examples are not listed in priority order. Applicants are
encouraged to propose other topics consistent with the goals of this program
announcement.
o Conduct epidemiological studies to clarify the relation between caries in
the primary dentition and subsequent caries in the permanent dentition;
o Conduct longitudinal studies on incidence and risk factors for
diseases/conditions such as coronal and root caries, and periodontal
diseases, persistent orofacial pain, salivary gland disease, and oral
conditions associated with diabetes;
o Conduct case-control studies to assess risk for orofacial pain or
craniofacial deformities;
o Investigate links between biologic, behavioral, environmental, and genetic
factors associated with the incidence of oral cancer and survival;
o Assess knowledge, attitudes, and behaviors of the public and health care
providers as related to the oral effects of tobacco use, prevention of
craniofacial injury, and between aging and oral disease or compromised oral
function;
o Develop and test methods to encourage attitudes and behaviors which support
oral health and that can be accepted and sustained in community settings;
o Study determinants of therapeutic adherence; test and develop methods to
enhance compliance with therapeutic or preventive oral health care
recommendations and compliance in clinical trials;
o Develop and assess measures to increase oral health literacy and enhance
effective transfer of knowledge to consumers regarding effective prevention
and treatment of oral disease;
o Conduct studies to assess the relation of oral health literacy and language
skills to oral health status and/or treatment outcomes;
o Conduct studies to enhance communication of oral health information and to
improve oral health outcomes within disadvantaged and underserved
populations;
o Conduct epidemiological studies to investigate environmental and behavioral
factors that contribute to higher prevalence of oral diseases/conditions in
disadvantaged and underserved populations;
o Develop and test community-based approaches for reducing oral
diseases/conditions, such as oral-facial trauma in adolescents or other high
risk groups;
o Develop improved methods to assess personal and social outcomes of dental
care and identify determinants of motivation to seek professional oral health
care;
o Determine the incidence and prevalence of oral and craniofacial diseases
and conditions in disadvantaged, high risk, and underserved populations for
whom nationally representative data are unavailable.
MECHANISM OF SUPPORT
This PA will use the NIH R01 award mechanism. However, if a clinical trial is
proposed under this PA, the U01 award mechanism will be used. As an
applicant, you will be solely responsible for planning, directing, and
executing the proposed project.
This PA uses just-in-time concepts. It also uses the modular budgeting as
well as the non-modular budgeting formats (see
http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if
you are submitting an application with direct costs in each year of $250,000
or less, use the modular budget format. Otherwise follow the instructions
for non-modular budget research grant applications. This program does not
require cost sharing as defined in the current NIH Grants Policy Statement at
http://grants.nih.gov/archive/grants/policy/nihgps_2001/part_i_1.htm.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals,
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
Intervention studies may be conducted within the scope of this PA. NIDCR has
established special requirements for applications involving research
conducted through randomized clinical trials as outlined on NIDCR’s home page
under the section titled Clinical Trials
(http://www.nidcr.nih.gov/clinicalTrials/Clinical_Trials_Program.asp ).
WHERE TO SEND INQUIRIES
We encourage your inquiries concerning this PA and welcome the opportunity to
answer questions from potential applicants. Inquiries may fall into two
areas: scientific/research and financial or grants management issues:
Direct your scientific questions about epidemiology research issues to:
Maria Teresa Canto, DDS, MPH
Director, Population Sciences Research Program
Clinical, Epidemiology & Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental & Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4AS43B
Bethesda, MD 20892-6401
Telephone:(301) 594-5497
Fax: (301) 480-8319
E-mail: maria.canto@nih.gov
Direct your scientific questions about behavioral, social science, or health
services research issues to:
Patricia S. Bryant, PhD
Director, Behavioral and Social Science Research Program
Clinical, Epidemiology & Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental & Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4AS43A
Bethesda, MD 20892-6401
Telephone:(301) 594-2095
Fax: (301) 480-8319
E-mail: patricia.bryant@nih.gov
o Direct your scientific questions about oral health disparities research
issues to:
Ruth Nowjack-Raymer, MPH, PhD
Director, Health Disparities Research Program
Clinical, Epidemiology & Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental & Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4AS43J
Bethesda, MD 20892-6401
Telephone:(301) 594-5394
Fax: (301) 480-8319
E-mail: ruth.nowjack-raymer@nih.gov
o Direct your questions about financial or grants management matters to:
Mary Daley
Grants Management Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN44B
Bethesda, MD 20892-6402
Telephone: (301) 594-4808
FAX: 301-480-3562
Email: daleym@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a Dun and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the
Universal Identifier when applying for Federal grants or cooperative
agreements. The DUNS number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The DUNS number
should be entered on line 11 of the face page of the PHS 398 form. The PHS
398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html
in an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
The tilte and number of this program announcement must be typed on line 2 of
the face page of the application form and the YES box must be marked.
APPLICATION RECEIPT DATES: Applications submitted in response to this program
announcement will be accepted at the standard application deadlines, which
are available at http://grants.nih.gov/grants/dates.htm. Application
deadlines are also indicated in the PHS 398 application kit.
SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in a
modular budget grant format. The modular budget grant format simplifies the
preparation of the budget in these applications by limiting the level of
budgetary detail. Applicants request direct costs in $25,000 modules.
Section C of the research grant application instructions for the PHS 398
(rev. 5/2001) at http://grants.nih.gov/grants/funding/phs398/phs398.html
includes step-by-step guidance for preparing modular grants. Additional
information on modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR:
Applications requesting $500,000 or more in direct costs for any year must
include a cover letter identifying the NIH staff member within one of NIH
institutes or centers who has agreed to accept assignment of the application.
Applicants requesting $500,000 or more in direct costs for any year must
carry out the following steps:
1) Contact the IC program staff at least 6 weeks before submitting the
application, i.e., as you are developing plans for the study;
2) Obtain agreement from the IC staff that the IC will accept your
application for consideration for award; and,
3) Identify, in a cover letter sent with the application, the staff member
and IC who agreed to accept assignment of the application.
This policy applies to all investigator-initiated new (type 1), competing
continuation (type 2), competing supplement, or any amended or revised
version of these grant application types. Additional information on this
policy is available in the NIH Guide for Grants and Contracts, October 19,
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and five signed photocopies in one
package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
APPLICATION PROCESSING: Applications must be mailed on or before the receipt
dates described at
http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will
not accept any application in response to this PA that is essentially the
same as one currently pending initial review unless the applicant withdraws
the pending application. The CSR will not accept any application that is
essentially the same as one already reviewed. This does not preclude the
submission of a substantial revision of an unfunded version of an application
already reviewed, but such application must include an Introduction
addressing the previous critique.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
PEER REVIEW PROCESS
Applications submitted for this PA will be assigned on the basis of
established PHS referral guidelines. Appropriate scientific review groups
convened in accordance with the standard NIH peer review procedures
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific
and technical merit.
As part of the initial merit review, all applications will:
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit, generally the top half of applications under
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by an appropriate national advisory council
or board
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health. In
the written comments, reviewers will be asked to evaluate application in
order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of these goals. The scientific review
group will address and consider each of the following criteria in assigning
the application’s overall score, weighting them as appropriate for each
application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be judged
likely to have major scientific impact and thus deserve a high priority
score. For example, an investigator may propose to carry out important work
that by its nature is not innovative but is essential to move a field
forward.
SIGNIFICANCE: Does this study address an important problem? If the aims of
the application are achieved, how will scientific knowledge be advanced? What
will be the effect of these studies on the concepts or methods that drive
this field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or methods?
Are the aims original and innovative? Does the project challenge existing
paradigms or develop new methodologies or technologies?
INVESTIGATOR: Is the investigator appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to the experience level
of the principal investigator and other researchers (if any)?
ENVIRONMENT: Does the scientific environment in which the work will be done
contribute to the probability of success? Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements? Is there evidence of institutional support?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the sections on
Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
Sharing Research Data
Applicants requesting $500,000 or more in direct costs in any year of the
proposed research are expected to include a data sharing plan in their
application. The reasonableness of the data sharing plan or the rationale for
not sharing research data will be assessed by the reviewers. However,
reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or priority score.
BUDGET: The reasonableness of the proposed budget and the requested period
of support in relation to the proposed research.
AWARD CRITERIA
Applications submitted in response to a PA will compete for available funds
with all other recommended applications. The following will be considered in
making funding decisions:
o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Relevance to program priorities
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking $500,000 or more in
direct costs in any single year are expected to include a plan for data
sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing. Investigators should seek
guidance from their institutions, on issues related to institutional
policies, local IRB rules, as well as local, state and Federal laws and
regulations, including the Privacy Rule. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of the
research. This policy results from the NIH Revitalization Act of 1993 (Section
492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH Guidelines
for Inclusion of Women and Minorities as Subjects in Clinical Research -
Amended, October, 2001," published in the NIH Guide for Grants and Contracts
on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm.
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. You will find this policy announcement in the NIH Guide for Grants
and Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on
hESCs can be found at http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide, in the project
description and elsewhere in the application as appropriate, the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the “Standards for Privacy of Individually Identifiable Health Information”,
the “Privacy Rule,” on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as “covered entities”) must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on “Am I a covered
entity?” Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This PA
is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review. Awards are made under the authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and
284)and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All
awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The NIH Grants
Policy Statement can be found at
http://grants.nih.gov/grants/policy/policy.htm
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.